Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
FDA Recall #Z-1469-2025 — Class II — February 25, 2025
Product Description
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Reason for Recall
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
182,344 total units
Distribution
US Nationwide distribution.
Code Information
5400-010-000 UDI-DI: 07613327301663, Lot Numbers:2023011112, 2023020334, 2023072413, 2024032615; 5400-010-000ITL UDI-DI: 07613327359510, Lot Numbers: 2023022132 2023112213 2024020515 2024032013
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated